Reduced Calorie Diet Intervention in Kidney Transplant Recipients

The purpose of this study is to measure the effect of a reduced calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: reduced calorie diet

Detailed Description

Kidney transplantation is the preferred renal replacement therapy for end stage renal disease (ESRD) because it affords survival and quality of life advantages over maintenance dialysis.1 The number of transplants performed increases each year, with currently over 150,000 individuals living in the United States with a kidney transplant. This is in the setting of 68,000 patients on the wait list with a median wait time of 4 years for an available organ.2 Despite the survival benefit over dialysis, transplanted patients still have a greatly increased risk of cardiovascular disease (CVD) over the general population, and CVD is the leading cause of death among recipients with a functioning graft.3 Given the long wait times for kidneys due to organ shortage, extensive resources used, and support needed for each transplant procedure, it is imperative that we improve long term patient and graft survival. Accordingly, modification of CVD risk profile is of paramount importance in kidney transplant patients.

The etiology of increased risk of CVD in kidney transplant patients is multi-factorial and includes the high burden of CVD and its risk factors present prior to transplant, as well as increasing prevalence of these risk factors in the post transplant period due to transplant associated weight gain, immunosuppression side effects, metabolic consequences of a functioning kidney, and allograft dysfunction. Efforts to reduce CVD risk factors have yet to be adequately implemented and rigorously studied in the kidney transplant population.

Obesity at the time of transplant is common and associated with several CVD risk factors post transplant, including hypertension, hyperlipidemia, diabetes mellitus, metabolic syndrome, and inflammation. Obesity is also associated with potentially poorer graft outcomes, including death censored graft loss and chronic allograft failure.4 In addition, the majority of patients gain weight post transplantation, primarily in the form of fat mass. Post transplant weight gain is also associated with increased prevalence of known CVD risk factors, CVD death, and graft loss.5 The increased burden of CVD in kidney transplant patients makes obesity prevention and treatment strategies appealing interventions to improve long-term outcomes, both in terms of graft and overall survival. In this study we will measure the effect of a low calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years to 65 years;
• BMI 25 to 40 kg/m2;
• First time kidney transplant;
• Single organ transplant;
• Ability to understand and voluntarily provide informed consent.

Exclusion Criteria:

• Type 1 DM;
• Type 2 DM on diabetic medications/insulin;
• Biopsy proven acute rejection in the first 3 months post transplant;
• Active coronary disease;
• Immunosuppressive therapy at time of transplant (use prior to what is given for transplant procedure);
• Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
• Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: reduced calorie diet; 10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption	Other: reduced calorie diet; 10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption
No Intervention: standard diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
a significant improvement in measures of body composition (including weight, BMI, and fat mass)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
an improvement in insulin resistance	12 months
a decrease in oxidative stress markers	12 months
an improvement in kidney function	12 months

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Kelly A Birdwell, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: October 12, 2009
• First Submitted That Met QC Criteria: October 12, 2009
• First Posted (Estimate): October 14, 2009

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 091030